NCT02410486

Brief Summary

This prospective surveillance study will be conducted over a 2 year period to determine current rates of Early-Onset Sepsis (EOS)/ Early-Onset Meningitis (EOM), associated pathogens, antimicrobial resistance, signs and symptoms and infant outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
570

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Typical duration for all trials

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 7, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 11, 2019

Status Verified

March 1, 2019

Enrollment Period

2.7 years

First QC Date

April 2, 2015

Last Update Submit

March 8, 2019

Conditions

Infant, Newborn, DiseasesEarly Onset Neonatal SepsisEarly-Onset Meningitis

Outcome Measures

Primary Outcomes (2)

  • To determine current hospital-based rates of early-onset neonatal infection

    First 72 hours

  • To determine the antimicrobial susceptibility patterns of organisms associated with EOS and EOM

    First 72 hours

Secondary Outcomes (6)

  • To identify risk factors associated with EOS/EOM due to Gram-negative pathogens (case control comparison)

    First 72 hours

  • To determine the clinical signs/symptoms and laboratory abnormalities associated with EOS/EOM

    First 72 hours

  • To identify risk factors for EOS/EOM in infants born to mothers with chorioamnionitis (case control comparison)

    First 72 hours

  • To determine if term infants with EOS, identified because of maternal chorioamnionitis, can be asymptomatic at birth

    First 72 hours

  • To determine sepsis-associated mortality rates (total, GA-specific and BW-specific, pathogen-specific) for infants with EOS/EOM

    First 72 hours

  • +1 more secondary outcomes

Study Arms (5)

EOS infant / mother with chorio

Infant with EOS (Gram-positive or Gram-negative) and mother with Chorioamnionitis

EOS infant / mother without chorio

Infant with EOS (Gram-positive or Gram-negative) and mother without Chorioamnionitis

EOS Gram-neg infant / mother with chorio

Infant with Gram-negative EOS and mother with Chorioamnionitis

Gram-neg infant / mother without chorio

Infant with Gram-negative EOS and mother without Chorioamnionitis

Gram-pos infant / mother with chorio

Infant with Gram-positive EOS and mother with Chorioamnionitis

Eligibility Criteria

AgeUp to 72 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The study population will include all live born infants who are at least 22 weeks GA and have a birth weight \>400 grams and are delivered at NRN centers.

You may qualify if:

  • Case Surveillance: Live born infants with gestational age of at least 22 weeks and birth weight \>400 g and \<72 hours of age who are delivered at NRN hospitals and have early-onset sepsis and meningitis defined as isolation of a pathogen from blood or CSF obtained within 72 hours of birth and provision of appropriate antibiotic treatment for 5 or more days (or \<5 days if death occurs while receiving antibiotic therapy).
  • Controls: Live born infants with gestational age of at least 22 weeks and birth weight \>400 g who are delivered at NRN hospitals and have not been evaluated for early-onset sepsis (\<72 hours of age) or if evaluated, they have sterile blood and/or CSF cultures and were not treated with prolonged antibiotics for clinical "culture negative" sepsis. Controls for infants with Gram-negative infection will be infants without early-onset infection. Controls for infants born to mothers with clinical chorioamnionitis will be infants without early-onset infection born to mothers with clinical chorioamnionitis. Control infants will be born at the same hospital as cases, with the same gestational age grouping as cases (22 0/7 - 28 6/7 weeks; 29 0/7 - 33 6/7 weeks; 34 0/7 - 36 6/7 weeks; and ≥ 37 weeks).

You may not qualify if:

  • Stillbirths and infants who die in the delivery room will be excluded.
  • Infants who die within 12 hours of age will be excluded if they have not been evaluated for possible infection-ie, do not have a blood culture obtained to identify EOS.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

University of California - Los Angeles

Los Angeles, California, 90025, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

Emory University

Atlanta, Georgia, 30303, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

RTI International

Durham, North Carolina, 27705, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Cincinnati Children's Medical Center

Cincinnati, Ohio, 45267, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Research Institute at Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Brown University, Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02912, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75235, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (1)

  • Kilpatrick R, Greenberg R, Hansen NI, Shankaran S, Carlo WA, Cotten CM, Stoll BJ; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Use and utility of C-reactive protein (CRP) in neonatal early-onset sepsis: a secondary analysis of a prospective surveillance study. J Perinatol. 2025 Jan;45(1):139-145. doi: 10.1038/s41372-024-02064-5. Epub 2024 Aug 5.

    PMID: 39103472DERIVED

MeSH Terms

Conditions

Infant, Newborn, DiseasesNeonatal Sepsis

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesSepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Barbara Stoll, MD

    The University of Texas Health Science Center, Houston

    STUDY DIRECTOR

  • Michele Walsh, MD

    Case Western Reserve University, Rainbow Babies and Children's Hospita

    PRINCIPAL INVESTIGATOR

  • Seetha Shankaran, MD

    Wayne State University

    PRINCIPAL INVESTIGATOR

  • Abbot Laptook, MD

    Brown University, Women & Infants Hospital of Rhode Island

    PRINCIPAL INVESTIGATOR

  • Michael Cotten, MD

    Duke University

    PRINCIPAL INVESTIGATOR

  • Greg Sokol, MD

    Indiana University

    PRINCIPAL INVESTIGATOR

  • Abhik Das, PhD

    RTI International

    PRINCIPAL INVESTIGATOR

  • Krisa Van Meurs, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

  • Brenda Poindexter, MD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

  • Waldemar Carlo, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

  • Kristi Watterberg, MD

    University of New Mexico

    PRINCIPAL INVESTIGATOR

  • Myra Wyckoff, MD

    University of Texas, Southwestern Medical Center at Dallas

    PRINCIPAL INVESTIGATOR

  • Kathleen Kennedy, MD, MPH

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

  • Barbara Schmidt, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • Carl D'Angio, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

  • Pablo Sanchez, MD

    Research Institute at Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

  • William Truog, MD

    Children's Mercy Hospital Kansas City

    PRINCIPAL INVESTIGATOR

  • Uday Devaskar, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

  • Bradley Yoder, MD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2015

First Posted

April 7, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

March 11, 2019

Record last verified: 2019-03

Locations

US(20)